UK Offence Report

Suspension, etc., of a marketing authorisation

paragraph 38(4) of SCHEDULE 1 of The Veterinary Medicines Regulations 2005

The provision has been revoked and no saving provision preserving liability for earlier conduct was found.

What the provision says

4 When she suspends, varies or revokes

a marketing authorisation, the Secretary of State may additionally prohibit the supply of

a veterinary medicinal product, and if necessary require the marketing authorisation holder to recall the product; and failure to comply with

a requirement or prohibition under this sub-paragraph is an offence.

Text as made, from legislation.gov.uk. © Crown copyright, reused under the Open Government Licence v3.0. This is the text as originally made; later amendments are not shown here.

Who it binds, and what has to be proved

Binds
a marketing authorisation holder
Conduct
failing to comply with a notice or direction
Fault element
Strict liability
Burden of proof
Legal burden on the defendant

The prosecution must prove that the conduct happened. This is a strict liability offence as drafted: the provision uses no word of intention, knowledge, recklessness or negligence, so there is no need to show that a marketing authorisation holder meant to do it, knew about it, or was careless.

Intention, knowledge and carelessness are irrelevant to guilt. They may still matter a great deal to sentence.

The provision gives a defence the defendant must prove, on the balance of probabilities. A legal burden of that kind can be read down to a merely evidential one under section 3 of the Human Rights Act 1998 where placing it on the defendant would be disproportionate (R v Lambert [2001] UKHL 37; Sheldrake v DPP [2004] UKHL 43).

Classifier’s reasoning: no word of intention, knowledge, recklessness or negligence in the offence or its provision.

The defence, as drafted

an offence under these Regulations relating to advertising, it is a defence for the person charged to prove— a that he is a person whose business it is to publish or arrange for the publication of advertisements, and b that he received the advertisement in the ordinary course of business and did not know and had no reason to suspect that its publication would amoun

What would breach paragraph 38(4) of SCHEDULE 1?

These are illustrations, not law. They are generated from the provision’s own words to show the shape of the offence. Whether any particular conduct is caught depends on the full text, on any amendment since, and on the facts.

  1. Being served with a notice under the Veterinary Medicines Regulations 2005 and doing nothing by the date it specifies.
  2. Doing part of what the notice requires, where it required all of it.
  3. Disagreeing with the notice and ignoring it, rather than using whatever appeal the instrument provides.

Penalty

Mode of trial
Not determined
Maximum fine
Not determined
Maximum prison (summary)
Not determined

no penalty is stated in this instrument; it may be in the enabling Act, or in a general penalties provision this pass did not connect to the offence.

No penalty was determined from this instrument. It may be in the enabling Act, or in a general penalties provision this pass did not connect to the offence. Absence of a figure here is not evidence that the offence carries no penalty.

Sentencing

Offences of this kind are usually sentenced under the guidelines below. This is a mapping by subject, not a finding about this provision, and the links go to a search of the Sentencing Council’s own site.

Prosecution figures

The Ministry of Justice records offences under this instrument against offence code 9171 — 09171 - Triable either way offences under Veterinary Medicines Regulations 2005 and 2011. That code may cover several provisions of the instrument, so a count against it is not a count of prosecutions under this provision alone.

No published per-offence figure was found for this provision. Offences created by statutory instrument very largely do not have their own code in the MoJ’s Outcomes by Offence data tool. Absence of a figure is not evidence that the offence is unused.

Status and lifecycle

Current status
Revoked
Revoked by
The Veterinary Medicines Regulations 2006
Revoked on
1 October 2006
Made
6 October 2005
In force from
30 October 2005
Extent
Not stated

How this was established: the instrument was revoked by a later instrument found in this corpus.

What the instrument is for

(This note is not part of the Regulations) — the explanatory note published with the instrument, © Crown copyright.

These Regulations make provision for the authorisation, manufacture, classification, distribution and administration of veterinary medicinal products. They revoke and amend the provisions set out in Parts 1 to 3 of Schedule 8, provide transitional provisions in Part 4 of that Schedule, and provide that the Medicines Act 1968 no longer regulates veterinary medicinal products. They implement Directive 2001/82/EC of the European Parliament and of the Council on the Community Code relating to veterinary medicinal products (OJ No. L311, 28.11.2001, p.1), as amended by Directive 2004/28/EC (OJ No. L136, 30.4. 2004, p.58). They also identify the competent authority for, and provide for enforcement of, Regulations (EC) No. 178/2002 (OJ No. L31, 1.2.2002, p.1), (EC) No. 1831/2003 (OJ No. L268, 18.10.2003, p.29), (EC) No. 882/2004 (corrected version at OJ No. L191, 28.5.2004, p.1) and (EC) No. 183/2005 (OJ No. L35, 8.2.2005, p.1), in so far as they apply to veterinary medicinal products used in feedingstuffs, and to the following additives used in feedingstuffs: a coccidiostats; b histomonostats; c all other zootechnical additives except — i digestibility enhancers; ii gut flora stabilisers; and iii substances incorporated with the intention of favourably affecting the environment. In addition they implement Council Directive 90/167 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community (OJ No. L92, 7.4.90, p.42) so far as they are not rendered spent by Regulation (EC) No. 183/2005. They provide that a veterinary medicinal product must have a marketing authorisation granted by the Secretary of State before being placed on the market, and make provision for the grant of a marketing authorisation (regulation 4 and Schedule 1). They specify that a veterinary medicinal product must be manufactured by a person holding a manufacturing authorisation, and make provision for granting an authorisation (regulation 5 and Schedule 2). They regulate supply and possession of veterinary medicinal products, and introduce new classifications of those products (regulation 7 and Schedule 3). They provide that a veterinary medicinal product may only be administered as specified in its marketing authorisation or, in the case of administration by a veterinary surgeon, administration under the “cascade” (regulation 8 and Schedule 4). They control bringing a veterinary medicinal product into the United Kingdom (regulation 9) and advertising (regulation 10 to 12). They control wholesale dealing (regulation 13). They control medicated feedingstuffs and feedingstuffs containing additives specified in the Regulations (regulation 14 and Schedule 5). They provide for exemptions (regulation 15 and Schedule 6). They provide for fees (regulation 16 and Schedule 7). They require records to be kept (regulations 17 to 24). They create offences of importation, possession and supply of unauthorised veterinary medicinal products (regulations 25 to 27). They make provision for the existence of the Veterinary Products Committee (regulation 28). They make provision for a representations procedure in the case of a refusal, etc., of a marketing authorisation (regulation 29). They create administrative arrangements for the enforcement of the Regulations (regulations 32 to 41). Under regulation 42 breach of the Regulations is an offence punishable — a on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three months or both, or b on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both. A Regulatory Impact Assessment has been prepared and placed in the libraries of both Houses of Parliament. It is available on www.vmd.gov.uk at “Publications, Veterinary Medicines Regulations 2005”. A transposition note has been prepared and is available at www.vmd.gov.uk at “Publications, Veterinary Medicines Regulations 2005”.

Read the full note and every offence in this instrument

What Parliament said

Mentions of this instrument in Hansard. Parliamentary material is reused under the Open Parliament Licence v3.0.

Other offences in the same instrument

How this was identified as an offence

Everything above rests on the judgement that this provision creates a criminal offence, rather than mentioning one. That judgement is made by rule, from the words of the provision, and this is the rule that made it — with a confidence of 0.88.

Basis
the provision says the conduct “is an offence”; the provision says an offence is committed “if” something happens
Confidence
0.88 of 1.00

A provision that states a penalty for an offence created elsewhere can read very like one that creates an offence, and the rules can mistake the one for the other. If the text quoted above sets a penalty for something made an offence by another provision, treat the classification on this page with that in mind, and read the instrument.

Check the source